SOLICITATION NOTICE
65 -- Valley Biomedical / Human Serum AB - Heat Inactivated.
- Notice Date
- 8/4/2020 11:18:49 AM
- Notice Type
- Presolicitation
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH - CC BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 20-012446
- Response Due
- 8/11/2020 11:00:00 AM
- Archive Date
- 08/26/2020
- Point of Contact
- Grace Wong-Darko, Phone: 3014961199
- E-Mail Address
-
Grace.Wong-Darko@nih.gov
(Grace.Wong-Darko@nih.gov)
- Description
- INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Department of Transfusion Medicine (DTM), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (including brand-name) to: Valley Biomedical Products & Services Inc 121 Industrial Dr. Winchester, VA 22602-2583 United States NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 325413 with a Size Standard 1,250. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2020-08, July 14, 2020. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold. STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. GENERAL INFORMATION 1. Title: Valley Biomedical / Human Serum AB - Heat Inactivated. 2. Background Information: �The Cell Processing Section (CPS) is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes to support more than 50 intramural clinical trials. These services include (1) development, evaluation, and validation of investigational new drugs (INDs) for cellular therapies and (2) manufacture of cellular therapy products for approved clinical trials. The majority of these trials are early phase (I/II) trials not intended to result in the development of a commercial product. To provide these services, CPS operates a core facility for the manufacture, storage, and distribution of cellular therapy products. CPS manufactures cellular therapy products from more than 800 collections from patients or healthy donors per year. The products manufactured by the laboratory are used to treat NIH CC patients with cancer, hematological malignancies, marrow failure, genetic immune disorders and autoimmune diseases. All products are manufactured using good manufacturing practices (GMP). The NIH protocols are institutional review board (IRB) approved and in the case of INDs, approval by the US Food and Drug Administration (FDA) for treatment of human subjects. Each subject must consent to participate in a NIH Clinical Research Study. 3. Purpose or Objective: This contract is to purchase supplies aiding in the culture of cellular therapy products.� The intended use for the heat inactivated human AB serum is set forth by the investigator and is protocol specific.� Currently the reagent is used to aid in the culture of clinical cellular therapy products including but not limited to:� Preparation of Autologous Transduced Lymphocytes Expressing Anti-CD22 Chimeric Antigen Receptor, T Cells expressing a fully-human anti-CD30 Chimeric Antigen Receptor for treating CD30-expressing lymphomas, Isolation and Ex Vivo Expansion of Autologous Marrow Derived Mesenchymal Stromal Cells for Intra-Myocardial Injection, and Transduction of Autologous T Cells with anti-HPV-16 E7 T-Cell Receptor 4. Period of Performance: Base year with an approximately start date on or around 9/1/20. CONTRACTOR REQUIREMENTS (SCOPE OF WORK) 1. The contractor will supply sufficient reagents and disposables to process approximately 150 cellular therapy products per year. 2. Shelf Life-Minimum - shelf life of any unopened reagent shall be at least 1 year from receipt unless otherwise agreed to from date of delivery at the DTM Cell Processing Laboratory. ���������������������������� 3. The reagents and disposables may include but not limited to those listed below: Heat inactivated, Human AB Serum- plasma derived- HP1022HI 100mL bottle. 4. The Contractor shall supply technical support for all reagents and supplies and their performance characteristics at no additional cost to the Government. Period of Performance The period of performance for these product is one year: 09/1/2020 � 8/31/2021 Delivery Schedule: 375 bottles to be delivered in September of 2020 375 bottles to be delivered in August of 2021 These reagents/disposables will be shipped for overnight delivery Monday through Thursday to: ����������� �������� NIH/CC/DTM/Center Cellular Engineering �������� 10 Center Drive �������� Bldg. 10/ Rm. 3C720 ���������Bethesda, MD 20892-1288 ���������Attention:� Timmy Ton Shipments will use government carrier at the expense of the government unless otherwise arranged. The contractor shall bear the cost of replacement for reagents and disposables found to be damaged or defective upon receipt by NIH or for incorrect or incomplete shipments. Government Responsibilities 1.������ The Cell Processing Section shall use the reagents in accordance with manufacturer�s package inserts and approved IND/IDE uses if applicable. 2.������ The NIH CC Center Cellular Engineering shall inspect shipments upon receipt and report any damage, defects or errors in shipment to the contractor.� CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION This system is on site and has been validated for use on CC patients.� It would be detrimental to the government to attempt to change systems and quite impossible as these instruments/supplies are proprietary and only distributed by Valley Biomedical. �With the continuation of using the same system will also help reduces the risk of a disruption in patient care. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. � A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by August 11th, 2020, 2:00 PM Eastern time and must reference solicitation number 20-012446. Responses may be submitted electronically to Mrs. Grace Wong-Darko, Contracting Specialist at Grace.Wong-Darko@nih.gov. Fax responses will not be accepted. ""All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.""
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/cbd6521966f7477b89623667587f5893/view)
- Place of Performance
- Address: Bethesda, MD 20892, USA
- Zip Code: 20892
- Country: USA
- Zip Code: 20892
- Record
- SN05744948-F 20200806/200804230152 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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